Pet food for maintenance of joint health and alleviation of arthritic symptoms in companion animals

ABSTRACT

A pet food product and process for producing the pet food product for use in maintenance of healthy joints and alleviation of arthritic symptoms in companion animals, the pet food comprising an effective amount of an active extract of  Perna canaliculus.  The extract can be either a powder or lipid extract. Preferably in an amount that provides for a dosage range of generally 0.18 to 114 mg of a powder extract/kg of body weight/day in a companion animal or an amount of generally 1.5 to 1000 mg of a powder extract of  Perna canaliculus  per 400 kcal of pet food product.

[0001] This application is a continuation of U.S. application Ser. No.09/273,933 filed on Mar. 22, 1999.

FIELD OF THE INVENTION

[0002] The present invention relates to pet food for companion animals,and more particularly to pet food that includes an active quantity of anextract of Perna canaliculus in an amount that will provide a daily petdiet for the maintenance of joint health and for the alleviation ofarthritic symptoms in companion animals such as dogs, cats and horses.

BACKGROUND OF THE INVENTION

[0003] The connective tissues of humans and non-human animals areconstantly subject to stresses and strains from mechanical forces thatcan result in afflictions, such as arthritis (both rheumatoid andosteoarthritis), joint inflammation and stiffness. This is true for bothhumans and non-human animals, and particularly as they age. Theunderlying causes of rheumatoid arthritis and/or osteoarthritis aredifferent such that rheumatoid arthritis is characterized as anautoimmune disease affecting both the joints and systemic immunefunctions, whereas osteoarthritis results from deterioration of thearticular cartilage which may result in local inflammation of thejoints. While a greater portion of humans with arthritis have rheumatoidarthritis, most of the arthritis occurring in companion animals isosteoarthritis.

[0004] In osteoarthritis or degenerative joint disease, increased stressin the joints results in loss of the integrity of the cartilage matrixand the resulting damage causes the accelerated destruction of cartilagecomponents and synovial fluid. The connective tissues are naturallyequipped to repair themselves by manufacturing and remodeling prodigiousamounts of collagen (a chief component of connective tissue) andproteoglycans—the other major component of connective tissues. Withaging, there is a decreased ability to restore and synthesize normalcollagen structures. This results in pain, deformity and limitation ofjoint motion.

[0005] In dogs, osteoarthritis is a disorder of the synovial jointswhich is characterized by degeneration of the articular cartilage and byformation of new bone at the joint margins. Hardening of the underlyingsubchondral bone may also be a feature of osteoarthritis and in somecases, a variable degree of synovial inflammation may be present at sometime during the progression of the disease.

[0006] The treatment of connective tissue afflictions in both humans andnon-human animals can be quite problematic. A simple decrease in thestresses to which the connective tissue is subject is often not usuallyan option. Consequently, treatment is often directed at controlling thesymptoms of the afflictions and not their causes, regardless of thestage of the degenerative process. Presently, steroids such ascorticosteroids and other anti-inflammatory materials, such as highdoses of aspirin are widely used for the treatment of these afflictionsin humans. In veterinary medicine, hyaluronic acid and polysulfonatedgylcosaminoglycan are used, particularly for equines to reduceconnective tissue pain and swelling. While these materials often relievethe pain and swelling associated with maladies arising from connectivetissue problems, almost all drugs eventually lose their effectiveness.

[0007] Natural products derived from plants and food have frequentlybeen the source of effective drugs, and in recent years there has beenan increased interest in the analysis of these natural products,especially where a clinical benefit is claimed. Compounds that have beenidentified in foods and may be of clinical benefit are the orallyadministered chondroprotective agents, glucosamine and chondrotinsulphate, which in the body, are normal constituents of articularcartilage. There are studies to suggest that these agents might beeffective in humans in the treatment of osteoarthritis. However, thereare few reports in the veterinary literature of the clinical efficacy ofthese oral chondroprotective agents in dogs and other animals.

[0008] In the category of natural food products, it has been found thatcertain marine organisms contain compounds that when fed to animals aidin the treatment of inflammation. One of these marine organisms is Pernacanaliculus (New Zealand Green Lipped Mussel) in which itsanti-inflammatory activity was first identified in a clinical study onleukemia.

[0009] Initial assessment of the anti-inflammatory activity of Pernacanaliculus was first attempted using a polyarthritis model in rats.(Cullen et al. 1975.) These studies, however, failed to show thepresence of any significant anti-inflammatory activity in the musselpreparation. In contrast, Miller and Ormrod (1980), using acarrageenan-induced paw edema assay (Winter et al. 1962), were able toshow that mussel preparations, when administered intraperitoneally, gavea significant reduction to the swelling of a carrageenan-inducted ratpaw edema. Subsequently, they fractionated a non-dialysable,water-soluble fraction from the mussel preparation that possessed theanti-inflammatory activity. The aqueous extract showed a dose-dependentanti-inflammatory activity when administered intraperitoneally whichcould not be detected upon oral administration of the mussel powder. Itwas suggested that the water-soluble fraction therefore contained anirritant component possessing apparent anti-inflammatory activity.

[0010] Rainsford and Whitehouse (1980) also reported that freeze-driedpowder preparations of the whole mussel given orally to rats showed somemodest anti-inflammatory activity in the carrageenan-induced paw edemaassay, and that this material strikingly reduced the gastriculcerogenicity of several non-steroidal anti-inflammatory drugs in ratsand pigs. In another study, Korthauer and Delatorre (1992) found thatthe oral administration of a glycosaminoglycan extracted from Pernacanaliculus to 26 dogs with arthritis at 10 mg/kg daily for eight weeksalleviated the signs of lameness or faulty posture in a highproportionate number of dogs in the study.

[0011] Macrides and Kalafatis, the named inventors of WO 96/05164 for ananti-inflammatory preparation, have established that lipid fractionsfrom Perna canaliculus (in contrast to earlier work on aqueousfractions) are a rich source of compounds which in semipurifiedextracts, have shown a measure of anti-inflammatory activity when testedin appropriate model systems. In WO 96/05164, a purified active fractionisolated from a lipid extract of Perna canaliculus or Mytilus edulis,has an active component that has been shown to have anti-inflammatoryproperties. From this active component, a substantially pure form of5,11,14,17-eicosatetraenoic acid (an omega 3 fatty acid) has beenisolated and pharmaceutically acceptable esters, amides and saltsthereof have been identified. This compound may be a major constituentof the active fraction isolated from the lipid extract of Pernacanaliculus. The lipid extract when fed orally has been shown to reduceinflammation in rats. (Whitehouse et al. 1996.)

[0012] While the exact mechanism of Perna canaliculus on arthriticsymptoms is unknown, it is thought to be partly due to the presence of aunique eicosatetraenoiec acid (ETA) as well as other unique fatty acidsthat appear to alter the production of inflammatory agents in the bodyvia the lipoxygenase pathway. As previously discussed, the lipid extractof Perna canaliculus contains a high percentage of these fatty acids andthe powder form contains small amounts of the same fatty acids as wellas other nutrients such as complex proteins, glycosaminoglycans,vitamins, minerals and amino acids, that may act in synergism toregenerate damaged articular cartilage and synovial fluid. Inunderstanding the ideology of the two main types of arthritis, the lipidextract may be more affective in treating animals and/or individualswith rheumatoid arthritis since studies have shown that omega-3 fattyacids can reduce synovial and systematic inflammatory response. (Volkeret al. 1996.) As for the powder form, it may be more beneficial intreating individuals with osteoarthritis since it also containsglycosaminoglycans and other nutrients that might potentially help toregenerate articulate cartilage in the joints. These compounds may alsohelp to maintain joint health in animals not yet exhibiting arthriticsymptoms.

[0013] Based on the apparent effectiveness of a Perna canaliculusextract as an anti-inflammatory agent, it would be beneficial to providea pet food that includes a quantity of an active extract of Pernacanaliculus in an amount that will provide a pet diet for themaintenance of joint health and the alleviation of arthritic symptoms incompanion animals such as dogs, cats and horses.

BRIEF SUMMARY OF THE INVENTION

[0014] An object of the present invention is a pet food product thatincludes an active extract of Perna canaliculus for the maintenance ofjoint health in companion animals.

[0015] An additional object of the invention is a pet food product thatincludes an active extract of Perna canaliculus for the alleviation ofarthritic symptoms in companion animals.

[0016] A further object of the invention is a process for producing apet food product that includes an active extract of Perna canaliculusfor the maintenance of joint health and the alleviation of arthriticsymptoms in companion animals.

[0017] An additional object of the invention is a process of feedingcompanion animals a diet comprising a pet food product containing aneffective amount of an active extract of Perna canaliculus for themaintenance of joint health and alleviation of arthritic symptoms incompanion animals.

[0018] Thus, in accomplishing the forgoing objects there is provided inaccordance with one aspect of the present invention, a pet food productfor companion animals that comprises an effective amount of an activeextract of Perna canaliculus for the maintenance of joint health andalleviation of arthritic symptoms in companion animals. In specificembodiments the extract can be either a powder or lipid extract.

[0019] In additional embodiments, the invention includes a process forproducing a pet food product for companion animals that includes thestep of adding an effective amount of an active extract of Pernacanaliculus to the pet food product for the maintenance of joint healthand alleviation of arthritic symptoms in companion animals. The extractof Perna canaliculus maintains its activity throughout the process ofproduction.

[0020] Another specific embodiment includes a process for maintainingjoint health and alleviating arthritic symptoms in companion animals byfeeding the companion animal a diet comprising a pet food productcontaining an effective amount of an active extract of Perna canaliculusfor the maintenance of joint health and alleviation of arthriticsymptoms in companion animals.

[0021] A further specific embodiment includes a pet food productcomprising an active powder extract of Perna canaliculus in an amountthat provides for a dosage range of generally 0.18 to 114 mg of powderextract/kg of body weight/day in a companion animal.

[0022] Another specific embodiment includes a pet food productcomprising generally 1.5 to 1000 mg of active powder extract of Pernacanaliculus per 400 kcal of pet food product.

[0023] A further specific embodiment includes a pet food productincluding a lipid extract in an amount that provides for a dosage rangeof generally 1.0 to 13 mg of lipid extract/kg/day in a companion animal.

[0024] Another specific embodiment includes a pet food product includinga lipid extract in an amount that provides for about 10.0 to 100 mg ofactive lipid extract of Perna canaliculus per 400 kcal of pet foodproduct.

[0025] Other and further objects, features, and advantages will beapparent from the following description of the presently preferredembodiments of the invention, which are given for the purpose ofdisclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026]FIG. 1 shows the influence of Green Lipped mussel on arthriticsymptoms at 0 and 6 weeks of treatment. * Represents significantdifferences from baseline scores (p>0.05).

[0027]FIG. 2 shows the influence of different doses of Green LippedMussel powder (GLMP) on total arthritic scores at 3 weeks and 7 weeks.^(*),⁺Represent differences only within each group between thetimepoints at a level of p<0.05. Significant differences were observedbetween the Baseline, 3 week and 7 week timepoints in the 50, 100 and200% dosages. ^(a),^(b) Represent after 7 weeks of treatment;differences were observed between the control and the treatment group.

DETAILED DESCRIPTION OF THE INVENTION

[0028] The present invention is directed to pet food products such aswet and semi-moist pet food, dry kibble, treats and a pet drink thatcontain an effective amount of an active extract of Perna canaliculusfor maintaining joint health and alleviating arthritic symptoms incompanion animals such as dogs, cats and horses.

[0029] Although the underlying mechanism in alleviating arthriticsymptoms by extracts of Perna canaliculus (Green Lipped Mussel) have notbeen well characterized, it has been shown that extracts of Pernacanaliculus in both the powder and lipid form are efficacious inalleviating arthritic symptoms in dogs. Even though both the powder andlipid extracts have been found to be effective, the Green Lipped Musselpowder (GLMP) may be a more efficacious treatment for osteoarthriticanimals because it helps address both a cause (regeneration of cartilageand synovial fluid) and effect (anti-inflammatory effects) ofosteoarthritis.

[0030] An “extract” of Perna canaliculus is considered to be either apowdered form of the entire Perna canaliculus or a concentratedpreparation of the lipid portion of the Perna canaliculus.

[0031] A compound or composition is said to be “acceptable” if itsadministration can be tolerated by a recipient mammal. Such an agent issaid to be administered in an “effective amount” if the amountadministered is physiologically significant. An agent is physiologicallysignificant if its presence results in technical change in thephysiology of a recipient mammal. For example, in the alleviation ofarthritic symptoms in companion animals, an agent which slows theprogression of the disease and/or symptoms or completely treats thedisease and/or symptoms, would be considered effective.

[0032] The dosages given as examples herein are the dosages determinedby the studies. The dosages administered are an effective amount ofactive ingredient and will, of course, vary depending upon known factorssuch as the pharmacodynamic characteristics of the particular activeingredient and its mode and route of administration; the age, sex,health and weight of the companion animal; nature and extent ofsymptoms; kind of concurrent treatment, frequency of treatment and theeffect desired.

[0033] A daily dosage (effective amount) in a range of about 0.18 to 114mg of active GLMP/kg of body weight/day is efficacious in alleviatingarthritic symptoms in companion animals and likewise would also maintainjoint health. More preferably, a dosage range of 1.8 to 85 mg of GLMP/kgof body weight/day, and most preferably, a dosage range of 9 to 58 mg ofGLMP/kg of body weight/day would be efficacious in maintaining jointhealth and alleviating arthritic symptoms in companion animals. Thisdosage equates to a 22 kg dog receiving 0.45 g/day or 0.02 g/kg of bodyweight/day of GLMP. In a 454.5 kg horse, the dosage would be 10 g/day or0.02 g/kg of body weight/day of GLMP. The dosage level for a cat wouldbe the amount required to reach a level of 0.02 g/kg of body weight/dayof GLMP.

[0034] The amount of active GLMP that is necessary per 400 kcal of a petfood product to be efficacious in maintaining joint health andalleviating arthritic symptoms in companion animals, and mostparticularly dogs, is generally 1.5 mg to 1000 mg of GLMP/400 kcal ofpet food. More preferably an amount of 15 mg to 750 mg of GLMP/400 kcaland most preferably, an amount of 75 mg to 520 mg of GLMP/400 kcal of apet food product to be efficacious in the maintenance of joint healthand alleviating arthritic symptoms in companion animals.

[0035] A daily dosage (effective amount) of the lipid extract of about1.0 to 13 mg/kg of body weight/day and a most preferred dosage of 4.6 to5.1 mg/kg of body weight/day is efficacious in alleviating arthriticsymptoms in companion animals and likewise would also maintain jointhealth. A dosage based on mg/400 kcal is about 10.0 to 100 mg of thelipid extract/400 kcal of pet food and more preferably, 33 to 40 mg ofthe lipid extract/400 kcal of a pet food product to be efficacious inthe maintenance of joint health and alleviating arthritic symptoms incompanion animals.

[0036] New and novel pet food products have been developed that containan active extract of Perna canaliculus or its equivalent (i.e. anextract of Mytilus edulis), in an amount that is efficacious inmaintaining joint health and alleviating arthritic symptoms in companionanimals. As is known to one skilled in the art, there are a variety ofcommonly known pet food products. In the area of cat and dog food, thereis wet pet food, semi-moist pet food, dry pet food and pet treats.Drinks for pets are also available such as milk drinks for cats. Wet petfood generally has a moisture content above 65%. Semi-moist pet foodtypically has a moisture content between 20-65% and can includehumectants such as propylene glycol, potassium sorbate, and otheringredients to prevent microbial growth (bacteria and mold). Dry petfood (kibble) generally has a moisture content below 20% and itsprocessing typically includes extruding, drying and/or baking in heat.Pet treats can typically be semi-moist chewable treats; dry treats inany number of forms; chewable bones; baked, extruded or stamped treats;confection treats; or other kinds of treats as is known to one skilledin the art. Horse food is typically dry and contains a mixture ofcereals and supplements.

[0037] A semi-moist pet food product generally includes ingredients suchas cereal grains, meats, fats, vitamins, minerals and functionalingredients that are blended together, cooked and packaged. However, anysemi-moist pet food formulation known to one skilled in the art can beused. For example, a pet food of the subject invention can be formed byadding to a basic semi-moist pet food formulation, about 10% by weightof GLMP. In this example of a semi-moist pet food, 4.5 grams of foodcontains approximately 2910 kcal/kg, which will deliver a GLMP dosagerange of 9 to 58 mg of GLMP/kg/day.

[0038] While a composition and process for producing a semi-moist petfood product has been generally described above, it should beappreciated that any semi-moist pet food composition and process knownto one skilled in the art can be used to produce a semi-moist pet foodproduct containing GLMP or the lipid portion.

[0039] In an example of a dry pet food, the ingredients generallyinclude cereal grains, meats, poultry, fats, vitamins, minerals andother functional ingredients. The ingredients are mixed and put throughan extruder/cooker. Thereafter, the product is cut or shaped and dried.After drying, flavors, fats and other functional ingredients can becoated or sprayed onto the dried product. The spray used is of a kindthat is known to one skilled in the art of producing dry pet food. Toproduce an example of a dry pet food of the subject invention, GLMP isadded to the product in the spraying process after it has been dried.This is achieved by incorporating GLMP into any known spray in an amountthat would provide a final concentration of GLMP in a range of generallybetween 0.06% w/w and 4.2% w/w. A spray mixture having this amount ofGLMP provides an inclusion level of generally 10% w/w of the GLMP. Theintact dry food is then spray coated with the GLMP spray mixture inwhich the final product has an inclusion level of GLMP that is generallyabout 1% w/w or below. This example of a dry pet food will deliver about3300 kcal/kg, which will give a GLMP dosage range of generally between75 mg to 520 mg/400 kcal.

[0040] While a composition and process for producing a dry pet foodproduct has been generally described above, it should be appreciatedthat any dry pet food composition and process known to one skilled inthe art can be used to produce a dry pet food product suitable forcoating with the GLMP or lipid portion.

[0041] A wet pet food and pet treats are produced as is known to oneskilled in the art depending upon the kind of wet pet food product andtreat desired. The procedure for adding the GLMP or lipid portion to anypet food product will depend upon the type of processing required tomanufacture the wet pet food or treat. For example, in semi-moisttreats, in which the processing temperature usually does not exceed50-70 degrees C., the active GLMP or lipid portion can be added to thetreat during processing. However, if the processing temperature of thetreat generally exceeds 70 degrees C., then the active GLMP or lipidportion can be coated on the finished product.

[0042] The anti-arthritic activity of the Perna canaliculus extract hasbeen shown to be sensitive to moisture, heat and light. Experimentationhas demonstrated that extrusion cooking of the Perna canaliculus extractabove 100 degrees C. destroys activity and that activity is onlymaintained with processing temperatures below 70 degrees C. In theprocessing of the semi-moist pet food, the temperature of processing hasbeen restricted to temperatures below that of extrusion cooking. TheGLMP added to the semi-moist product can be stabilized by the additionof anti-oxidant system composed of an organic acid and tocopherols suchas tartaric acid and vitamin E if desired. In the dry food product, theGLMP or lipid portion is added to the surface of the product at lowtemperatures in conjunction with surface spray ingredients. Theanti-arthritic activity of the Perna canaliculus extract is maintainedthroughout the manufacturing process in the semi-moist and dry pet foodproducts and pet treats by using this low temperature, stabilizationcriteria. However, any method used to protect the Perna canaliculusextract from degradation during processing, such as encapsulation or newprocessing technology, can be used to produce the inventive pet food.

[0043] Thus, as described, the present invention is a pet food productfor companion animals that includes a quantity of the active extract ofPerna canaliculus in an effective amount that will provide a pet dietfor the maintenance of healthy joints and alleviation of arthriticsymptoms in companion animals. The extract can be in either powder orlipid form. The present invention also includes a process for producingthe pet food product containing an amount of active Perna canaliculusextract and a process of feeding the companion animals the inventive petfood.

EXAMPLE 1 Influence of Green Lipped Mussel on Arthritic Symptoms

[0044] The effect of the Perna canaliculus extract in both powder andlipid form in alleviating osteoarthritic symptoms in dogs, wasdetermined wherein forty-seven mixed breed and sex adult dogs, rangingin age from 8-12 years, were fed a base diet consisting of a mix ofcanned and dry food. The dogs were divided into three groups. A controlgroup of 15 dogs was given a colored water placebo; another 15 dogs weregiven an oil supplement containing generally 80% mussel lipid extract,20% olive oil and vitamin E; and the other 17 dogs were given GLMP. Alipid extract without the olive oil and vitamin E would provide the sameeffect. The dosage for the oil supplement group was 216 mg/day for dogsweighing >75 lbs; 192 mg/day for dogs weighing between 55 to 75 lbs; and144 mg/day for dogs weighing <55 lbs. In the GLMP group, the dosage was1000 mg/day for dogs weighing >75 lbs; 750 mg/day for dogs weighingbetween 55 to 75 lbs; and 450 mg/day for dogs weighing <55 lbs. Thecontrol group was dosed at 1 ml for dogs weighing <55 lbs and 2 ml fordogs weighing >55 lbs. The GLMP and lipid compounds were provided byMcFarlane Laboratories Pty. Ltd., 410 Canterbury Rd., Surrey Hills,Victoria, 3127 Australia.

[0045] All dogs were assessed for arthritic symptoms visually andphysically by a veterinarian at baseline and again at six weeks. Factorsassessed at each time point included range of motion, mobility, painswelling and crepitus. These factors were used to calculate totalarthritic scores for the dogs. At the end of the six weeks, as shown inTable 1 and FIG. 1, the data showed that both the lipid and GLMP extractwere efficacious in alleviating arthritic symptoms, however, more dogsin the GLMP group improved or had greater reduction in arthriticsymptoms as compared to the lipid dosed group of dogs. TABLE 1 %Reduction in total arthritic Control Lipid GLMP scores (n == 15) (n =15) (n = 17) % of dogs with ≧ 30% 6.6% 46.7% 82.4% reduction in totalarthritic (1/15 dogs) (7/15 dogs) (14/17 dogs) scores % of dogs with ≧50% 0.0% 20.0% 35.5% reduction in total arthritic (0/15 dogs) (3/15dogs) (6/17 dogs) scores % of dogs with ≧ 70% 0.0% 13%   17.6% reductionin total arthritic (0/15 dogs) (2/15 dogs) (3/17 dogs) scores

EXAMPLE 2 The Influence of Different Dosages of GLMP on Total ArthriticScores

[0046] A second study was performed to evaluate whether different doselevels of GLMP would alleviate arthritic symptoms in dogs at an earliertime point or at a lower dose level. In this study, forty-seven mixedbreed and sex adult dogs, ranging in age from 8-12 years, were fed thesame basic diet. The dogs were divided into four groups. A control groupof 12 dogs was given a wheat flour placebo. A second group of 12 dogswas given a dosage of GLMP in an amount of 1000 mg/day for dogsweighing >75 lbs; 750 mg/day for dogs weighing between 55 to 75 lbs; and450 mg/day for dogs weighing <55 lbs which was 100% of the dosage givenin the initial study. A third group of 11 dogs was given a dosage ofGLMP in an amount of 500 mg/day for dogs weighing >75 lbs; 375 mg/dayfor dogs weighing between 55 to 75 lbs; and 225 mg/day for dogs weighing<55 lbs, which was 50% of the dosage given in the initial study. Afourth group of 12 dogs was given a dosage of GLMP in the amount of 2000mg/day for dogs weighing >75 lbs; 1500 mg/day for dogs weighing between55 to 75 lbs; and 900 mg/day for dogs weighing <55 lbs, which was 200%of the dosage given in the initial study.

[0047] All dogs were assessed for arthritic symptoms visually andphysically by a veterinarian at baseline and again at three and sevenweeks using the criteria established in the initial study. Asillustrated in Table 2 and FIG. 2, this study revealed that astatistically significant reduction in total arthritic score was foundafter seven weeks of treatment in the 50%, 100% and 200% dosage groupsas compared to their respective baseline time points and to the sevenweek control group score. Additionally, all the test groups showedstatistically significant reductions in total arthritic scores betweentheir respective third week and baseline time points. In the controlgroup, three week mean scores were significantly lower than baselinescores, but those differences were not seen at 7 weeks. TABLE 2 %Reduction Control GLMP GLMP GLMP in total (0%) (50%) (100%) (200%)arthritic scores (n = 12) (n = 11) (n = 12) (n = 12) % of dogs with 8.3%64% 50% 50% ≧ 30% (1/12 dogs) (7/11 dogs) (6/12dogs) (6/12 dogs)reduction in total arthritic scores % of dogs with 0.0% 45% 33% 33% ≧40% (0/12 dogs) (4/11 dogs) (4/12 dogs) (4/12 dogs) reduction in totalarthritic scores % of dogs with 0.0% 27% 8.3% 25% ≧ 50% (0/12 dogs)(3/11 dogs) (1/12dogs) (3/12 dogs) reduction in total arthritic scores %of dogs with 0.0% 18% 0.0% 25% ≧ 60% (0/12 dogs) (2/11 dogs) (0/12 dogs)(3/12 dogs) reduction in total arthritic scores

[0048] One skilled in the art will readily appreciate that the presentinvention is well adapted to carry out the objects and obtain the endsand advantages mentioned, as well as those inherent therein. Theinventive pet food products, methods for producing the pet foodproducts, and methods for feeding the pet food products to companionanimals for the maintenance of joint health and alleviation of arthriticsymptoms in companion animals described herein are presentlyrepresentative of the preferred embodiments, are exemplary, and are notintended as limitations on the scope of the invention. Changes thereinand other uses will occur to those skilled in the art which areencompassed within the spirit of the invention and are defined by thescope of the claims.

REFERENCES

[0049] All patents and publications mentioned in this specification areindicative of the level of those skilled in the art to which theinvention pertains. All patents and publications herein are incorporatedby reference to the same extent as if each individual publication wasspecifically and individually indicated to be incorporated by reference.All of the following references have been cited in this application:

[0050] WO 96/05164, Anti-Inflammatory Preparation, published Feb. 22,1996.

[0051] Cullen, J. C., Flint, M. H., and Leider, J. (1975) M. Z. Med. J.81:260-261.

[0052] Miller, T. E. and Ormrod, D. J. (1980), M. Z. Med. J. 92:187-193.

[0053] Winter, C. A., Risley, A. E. and Nuss, G. W. (1962) Prc. Soc.Exp. Biol. Med. 111:544-547.

[0054] Rainsford, K. D. and Whitehouse, M. W. (1980),Arzneim.-forsch./Drug Res. 30(ii), 2128-2132.

[0055] Korthauer, W. and Delatorre, J., Kleintierpraxis V. 37, No. 7;(1992) 467-768.

[0056] Whitehouse, M. W., Macrides, T. A., Kalafatis, N., Betts, W. H.,Hayes, D. R., and Broadbent, J, (1997) Inflammmopharmacology 5:237-246.

[0057] Volker, D., Garg, M. (1996) J. Clin. Biochem. Nutr. 20:83-97; andKramer, J. M., Lawrence, D. A., Jubiz, W., DiGiacomo, R., Rynes, R.,Bartholomew, L. E., and Sherman, M. (1990), Arthritis and Rheumatism33:810-820.

What is claimed is:
 1. A pet food product for companion animals, the petfood product comprising an effective amount of an active extract ofPerna canaliculus for the maintenance of joint health and alleviation ofarthritic symptoms in companion animals.
 2. The pet food product ofclaim 1, wherein the extract of Perna canaliculus is selected from agroup consisting of an active powder extract and a lipid extract.
 3. Thepet food product of claim 2, wherein the effective amount of activeextract is a powder extract in an amount that provides for a dosagerange of generally 0.18 to 114 mg of powder extract/kg/day in acompanion animal.
 4. The pet food product of claim 3, wherein theeffective amount is an amount that provides for a dosage range ofgenerally 9 to 58 mg of powder extract/kg/day in a companion animal. 5.The pet food product of claim 2, wherein the effective amount of activeextract is a powder extract in an amount that provides for about 1.5 to1000 mg of active powder extract of Perna canaliculus per 400 kcal ofpet food product.
 6. The pet food product of claim 5, wherein theeffective amount is an amount that provides for about 75 to 520 mg ofactive powder extract of Perna canaliculus per 400 kcal of pet foodproduct.
 7. The pet food product of claim 2, wherein the effectiveamount of active extract is a lipid extract in an amount that providesfor a dosage range of generally 1.0 to 13 mg of lipid extract/kg/day ina companion animal.
 8. The pet food product of claim 7, wherein theeffective amount is an amount that provides for a dosage range ofgenerally 4.6 to 5.1 mg of lipid extract/kg/day in a companion animal.9. The pet food product of claim 2, wherein the effective amount ofactive extract is a lipid extract in an amount that provides for about10.0 to 100 mg of active lipid extract of Perna canaliculus per 400 kcalof pet food product.
 10. The pet food product of claim 9, wherein theeffective amount is an amount that provides for about 33 to 40 mg ofactive lipid extract of Perna canaliculus per 400 kcal of pet foodproduct.
 11. The pet food product of claim 1, wherein the pet foodproduct is selected from a group consisting of a wet pet food, asemi-moist pet food, a dry pet food, a pet treat and a pet drink.
 12. Aprocess for producing a pet food product for companion animals, theprocess including the step of adding an effective amount of an activeextract of Perna canaliculus to the pet food product for the maintenanceof joint health and alleviation of arthritic symptoms in companionanimals, wherein the extract of Perna canaliculus maintains its activitythroughout the process.
 13. The process of claim 12, wherein the extractof Perna canaliculus is selected from a group consisting of an activepowder extract and a lipid extract.
 14. The process of claim 13, whereinthe effective amount of active extract is an amount of powder extractthat provides for a dosage range of generally 0.18 to 114 mg of powderextract/kg/day in a companion animal.
 15. The process of claim 14,wherein the effective amount is an amount that provides for a dosagerange of generally to 9 to 58 mg of powder extract/kg/day in a companionanimal.
 16. The process of claim 13, wherein the effective amount ofactive extract is an amount of powder extract that provides for about1.5 to 1000 mg of active powder extract of Perna canaliculus per 400kcal of pet food product.
 17. The process of claim 16, wherein theeffective amount is an amount that provides for about 75 to 520 mg ofactive powder extract of Perna canaliculus per 400 kcal of pet foodproduct.
 18. The process of claim 13, wherein the effective amount ofactive extract is a lipid extract in an amount that provides for adosage range of generally 1.0 to 13 mg of lipid extract/kg/day in acompanion animal.
 19. The process of claim 18, wherein the effectiveamount is an amount that provides for a dosage range of generally 4.6 to5.1 mg of lipid extract/kg/day in a companion animal.
 20. The process ofclaim 13, wherein the effective amount of active extract is a lipidextract in an amount that provides for about 10 to 100 mg of activelipid extract of Perna canaliculus per 400 kcal of pet food product. 21.The process of claim 20, wherein the effective amount is an amount thatprovides for about 33 to 40 mg of active lipid extract of Pernacanaliculus per 400 kcal of pet food product.
 22. The process of claim12, wherein the pet food product is selected from a group consisting ofa wet pet food, a semi-moist pet food, a dry pet food, a pet treat and apet drink.
 23. A process for maintaining joint health and alleviatingarthritic symptoms in companion animals by feeding the companion animala diet comprising a pet food product containing an effective amount ofan active extract of Perna canaliculus for the maintenance of jointhealth and alleviation of arthritic symptoms in companion animals. 24.The process of claim 23, wherein the extract of Perna canaliculus isselected from a group consisting of an active powder extract and a lipidextract.
 25. The process of claim 24, wherein the effective amount of anactive extract is an amount of powder extract that provides for a dosagerange of generally 0.18 to 114 mg of powder extract/kg/day in acompanion animal.
 26. The process of claim 25, wherein the effectiveamount is an amount that provides for a dosage range of generally 9 to58 mg of powder extract/kg/day in a companion animal.
 27. The process ofclaim 24, wherein the effective amount of an active extract is an amountof powder extract that provides for about 1.5 to 1000 mg of activepowder extract of Perna canaliculus per 400 kcal of pet food product.28. The process of claim 27, wherein the effective amount is an amountthat provides for about 75 to 520 mg of active powder extract of Pernacanaliculus per 400 kcal of pet food product.
 29. The process of claim24, wherein the effective amount of active extract is a lipid extract inan amount that provides for a dosage range of generally 1.0 to 13 mg oflipid extract/kg/day in a companion animal.
 30. The process of claim 29,wherein the effective amount is an amount that provides for a dosagerange of generally 4.6 to 5.1 mg of lipid extract/kg/day in a companionanimal.
 31. The process of claim 24, wherein the effective amount ofactive extract is a lipid extract in an amount that provides for about10 to 100 mg of active lipid extract of Perna canaliculus per 400 kcalof pet food product.
 32. The process of claim 31, wherein the effectiveamount is an amount that provides for about 33 to 40 mg of active lipidextract of Perna canaliculus per 400 kcal of pet food product.
 33. Theprocess of claim 23, wherein the pet food product is selected from agroup consisting of a wet pet food, a semi-moist pet food, a dry petfood, a pet treat and a pet drink.